Balloon tipped catheters have been developed in recent years to perform a variety of delicate operations within a living body. For example, Percutaneous Transuminal Coronary Angioplasty (PTCA) has been developed to open partially blocked coronary arteries. PTCA is performed by inserting a balloon tipped catheter into the blocked artery. When filled with fluid, the balloon opens the blocked artery. PTCA is often an alternative to coronary artery bypass surgery. The number of PTCA procedures is expected to increase from about 28,000 in 1983 to more than 75,000 in 1988.
The cost of catheters represents a significant portion of the overall cost of the procedures. PTCA catheters are quite expensive, costing several hundreds of dollars.
The reuse of such catheters would be a great help in controlling the spiraling cost of procedures utilizing catheters. Manual reprocessing of PTCA catheters has provided a limited means for reuse in catheters. Unfortunately, manual reprocessing is very prone to human error in that the sterility of manual reprocessed catheters is not assured as compared to new catheters. Also, manual systems for testing the catheter balloons are exceedingly difficult to control and may actually cause damage to the balloon. Additionally, manual systems fail to provide the necessary identification, monitoring, control and versatility required to produce a safe, efficient and practical catheter reprocessing system.
Allegedly, some manual reprocessing of balloon-tipped Catheters has taken place outside the United States.